Evaluating bacterial lethality of containerized food production

ABSTRACT

Procedures and means for evaluating effectiveness of bacterial-lethality, following batch-processed containerized food production operations and aseptic-flow food-production operations as containerized in aseptic-containers, in preparing for non-refrigerated marketing are described. The evaluations significantly expedite determining whether thermally-processed containerized food-production is safe for non-refrigerated marketing. The presence or absence of live spore-forming bacteria is determined chemically free of extended storage requirements relying on a mechanical-failure indication of food-spoilage. Also, a biological-indication verification of microbial-biocidal status of the packaged food is made available. The invention determines whether rigid-sheet metal containers, and/or whether any of the new, and newly developing, non-refrigerated food packages, which largely utilize polymeric materials, for convenient microwave-oven heating of opened-packs, and soft polymeric pouch products, are safe for non-refrigerated marketing; and, such determinations are made substantially more concurrently with production-operations, than previously available.

RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/674,610 filed Apr. 25, 2005.

INTRODUCTION

This invention relates to procedures and means for evaluatingeffectiveness of bacterial-lethality, following batch-processedcontainerized food production operations, including aseptic-packaging ofcontainerized foods, in preparation for marketing. More particularly,this invention is concerned with methods and apparatus for evaluatingresults of batch-food processing, in determining whether such foodproduction, as processed and containerized, is safe for non-refrigeratedmarketing.

OBJECTS OF THE INVENTION

A primary object is reliably evaluating bacterial-lethality resultingfrom thermal-processing carried-out in conjunction with containerizedbatch-food production operations.

A specific object is providing for test-ampoule constituents forevaluating bacterial-lethality results of such batch-foodthermal-processing.

A related object involves preparatory steps which facilitatethermal-processing which is protective of batch-food quality while suchfood is being prepared for non-refrigerated marketing.

A further related object provides methods and means for correlatingbacterial-lethality test determinations with bacterial-lethalityexperienced by the batch-food being processed.

Another object extends such evaluations to batch-food operationalsystems, such as:

(i) aseptic system flow-type thermal processing, followed bycontainerization in aseptic containers;

(ii) a coordinated batch-food preparation system in whichthermal-processing is substantially augmented and completed by impelledmovement of sealed suitably-rigid containerized food through selectedtravel-path of retort-equipment; and

(iii) a coordinated batch-food processing system for foods insubstantially non-rigid packages which remain essentially immobile, aspositioned for augmented and completed thermal-processing, in anenlarged retort chamber.

Other objects and a fuller understanding of the invention are presentedin the following description and claims, taken in conjunction with theaccompanying drawings, in which:

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic graphical presentation for describing relevanttemperature ranges for facilitating correlating test evaluations, withintest-ampoules of the invention, with bacterial-lethality experiencedwithin batch-food processed containers resulting from productionoperations;

FIG. 2 is a schematic graphical presentation for describing selectiveanalyses and preparatory steps of the invention for regulatingthermal-processing containerized batch-food production operations;

FIGS. 3(a) and 3(b) are elevational views for describingsubstantially-rigid types of test-ampoules as preferably used in testingsuitably-rigid type containers in accordance with the invention;

FIGS. 4(a) through 4(f) are perspective views for describing fabricationof pliable polymeric test-ampoules of as preferably used in testing withsubstantially non-rigid batch-processed food production packaging, inaccordance with the invention; in which:

FIG. 4(a) shows sealing at one longitudinal-end of elongated-tubularconfiguration formed from non-rigid polymeric sheet material;

FIG. 4(b) depicts later-described constituents as added within thepolymeric tubular-configuration of FIG. 4(a), so as to enablefabricating multiple individual test-ampoules of the invention from suchpolymeric tubular configuration, and

FIGS. 4(c)-4(f) are perspective views for describing equipment and stepsas combined for fabricating multiple such pliable polymerictest-ampoules of the invention, in which:

FIG. 4(c) shows heat-source apparatus, for sealing one longitudinal-endof such polymeric elongated tubular-configuration as shown in FIG. 4(a),and providing for follow-up forming multiple individual test-ampoules ofthe invention for use in relatively soft-packaged batch-food productionoperations in accordance with the invention;

FIG. 4(d) shows operational-closing of the heat-sealer structuralapparatus of FIG. 4(c) for describing specifics of the heat-sealing ofthe polymeric material, as relied-on, in the invention, for formingindividual test-ampoules containing test constituents; while

FIGS. 4(e) and 4(f) are perspective views for describing individualtest-ampoules of the invention and their fabrication from such polymericelongated-tubular configuration;

FIG. 5 is a schematic view of multiple-travel-path retort equipment forimpelled-movement, for describing concepts of the invention involvingpositioning a minimal number of rigid-type monitoring-containers, eachcontaining a test-ampoule, so as to facilitate determiningthermal-processing effectiveness on a substantially greater number ofcontainers, which are free of a test-ampoule, while beingpositionally-associated with monitoring-containers;

FIG. 5(a) combines an elevational cross sectional view of a rigidsheet-metal one-piece can body, and a top plan view of its end-closure,as preferred for use of rigid-type test-ampoules of the invention,during containerized batch-food processing production operations;

FIG. 5(b) is a schematic elevational view of non-rigid completedpackaging, combining polymeric laminated metallic foil and cardboard,for describing when and how to test for non-refrigerated marketing ascarried out in accordance with the invention;

FIG. 5(c) is a schematic view of completed packaging, combining aone-piece substantially-rigid polymeric can body which defines asingle-opening for an easy-open sheet metal end closure, for describingtesting as carried out in accordance with the invention;

FIGS. 5(d) and 5(e) are schematic views of relatively-thinpartially-pliable polymeric serving-tray and pan-like containerconfigurations, which are sealed with thin polymeric sheeting, fordescribing testing utilizing non-rigid polymeric-tubular-configurationtest-ampoules of the invention;

FIGS. 6(a) and 6(b) are schematic cross-sectional views of retort meansfor describing augmenting and/or completing thermal-processing ofnon-rigid polymeric pouches, and partially-pliable batch-food containersof the type shown in FIGS. 5(d) and 5(e), while such packaging remainssubstantially-stationary, in accordance with the invention within anenlarged temperature-controlled retort-chamber;

FIG. 7 is a box-diagram flow chart for describing aseptic-flow systemoperations in which thermal-processing is followed by containerizationin aseptic containers, while utilizing a concept of the invention, forminimizing test ampoule evaluations required for effectiveness of suchaseptic production operations.

FIG. 8 is a box-diagram flow-chart for describing added testing systemsof the invention and providing for minimizing the number of tests, inaccordance with the invention, for evaluating thermal-processingeffectiveness of added production operations for safe non-refrigeratedmarketing.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with long-established prior practice for non-refrigeratedfood marketing, batch-processed containerized rigid sheet metal canshave been and continue to be, utilized. Those cans have been, andcontinue to be, retained in non-refrigerated inventory for extended timeperiods, extending to four weeks, or more. Such detention periods havebeen, and are, relied on for detecting bulging or leaking mechanicalfaults due to the presence of food-spoilage bacteria, which had not beendestroyed by the thermal-processing during batch-processed containerizedfood production-operations.

The structural strength of currently-used rigid flat-rolled sheet-metalcans has been augmented by the use of one-piece can bodies which arefree of both a side-wall seam and a bottom end-wall seam. However, suchone-piece can bodies make it more likely that increased time intervalswill be required for inventory-storage-time, in order to detectmechanical faults, such as “end-bulging”, responsive to the presence oflive food-spoilage bacteria.

Concepts of the present invention are directed to chemically-basedevaluations of the effectiveness of thermal-processing, rather thanawaiting occurrence of mechanical faults or failures during inventorystorage. Such test evaluations, as taught herein, are carried outsignificantly more promptly, eliminating the prior practice which reliedon extended-inventory storage-times for “mechanical” failure todetermine whether thermally-processed contents of batch containerizedfoods were free of live food-spoilage bacteria.

The test-evaluations of the invention significantly expedite determiningwhether thermally-processed containerized food-production is safe fornon-refrigerated marketing. The presence or absence of livespore-forming bacteria is determined chemically; and, abiological-indicator verification of microbial-biocidal status of thepackaged food can also be made available. Present teachings determinewhether rigid-sheet metal containers, and/or whether the new, and newlydeveloping, non-refrigerated food packages, which largely utilizepolymeric materials, for convenient microwave-oven heating ofopened-packs, are safe for non-refrigerated marketing; and suchdetermination is made substantially more concurrently with theirproduction.

Whether thermal-processing as selected for particular containerizedproduction-operations has, or has not, accomplished “destruction” offood-spoilage bacteria, is determined; and, more specifically, thatdetermines whether timed-exposure, at a selected elevated-temperature,as part of thermal-processing production operations has, or has not,accomplished desired bacterial-lethality, so as to enablenon-refrigerated marketing. Also, such determinations are achieved inaccordance with the invention, free of extended storage requirementsrelying on a mechanical-failure indication of food-spoilage.

As taught, and provided for herein, microbial-biocidal test-ampoules andtest methods of the invention are correlated with batch-food productionoperations for expediting detection of the presence or absence ofspore-producing bacteria in containerized-food production. Further, abiological-indication for verification of biocidal-status is alsopreferably provided by establishing incubation conditions for test-meansof the invention. Biological-indication comprises a readily-acceptedsupplemental verification of the microbial-biocidal status; as towhether, or not, the particularly-processed containerized foodproduction is safe for non-refrigerated marketing; and, in addition,whether such food-production processing should continue is determined ina more timely manner than available when waiting for mechanicalfailures.

In practice of the invention individual test-ampoules are fabricated tohave sufficient internal volume so as to safely contain selectedlive-bacteria, plus liquid-state test constituents, as disclosed herein,during exposure to various temperatures levels. Bacteria for the testmeans are selected, as taught herein, to have thermal-responsecharacteristics which correlate with characteristics of bacteriaassociated with the containerized foods being processed.

Other contributions of the invention are concerned with:

(i) constructional and configurational concepts for certaintest-ampoules suitable for current and market-developing packaging;

(ii) coordinating requirements for qualifying particular test-ampoulesfor use with particular-developing types of containers fornon-refrigerated marketing; and

(iii) with optimizing test-ampoules and testing methods for differingtypes of batch-food production operations.

Use of rigid frangible materials, with properties similar to glass, inthe manufacture of test-ampoules of the invention; or, for practice oftesting methods of the invention, have purposefully been limited tosuitably-rigid containerized food production. That purpose is topreclude any potential that particulate, from frangible materials, frombecoming part of containerized food production. In addition, new pliabletest-ampoules as disclosed herein, are provided for newly-developingsoft-external packaging.

Test-ampoules and testing methods of the invention have also beendevised to be adaptable to widen application of developing types ofcontainerized production-operations, such as:

(i) aseptic-flow control which includes high-temperature-short-time(HT-ST) thermal-processing of the food, followed by containerization incustomized internal treatment of aseptic containers;

(ii) thermal-processing including in-line impelled movement ofsuitably-rigid containers, through defined travel-path retort-heatingequipment, and

(iii) augmented or completed thermal-processing, in which softerpackaging is maintained substantially-immobile in an enlarged,controllably-heated, retort chamber.

Qualifying characteristics have been established for polymeric materialsfor fabricating soft test-ampoules of the invention and for carrying-outtesting methods of the invention. Such qualifying characteristicsinclude:

(i) that test-ampoule materials do not react chemically with theinternal test-constituents of a functionally-complete test-ampoule, atany temperature encountered during production processing or duringtesting,

(ii) that test-ampoule structural materials be made available in a form,and with sufficient visual clarity, for promptly evaluating testresults, visually

(iii) that such test-ampoule materials provide sufficient strength forconfined sealing of selected constituents of a test-ampoule, and,

(iv) that such test-ampoule materials be capable of maintaining desiredstrength at elevated temperature(s) during production processing ofselected foods and testing thereof.

Additional concepts of the invention identify selections for correlatingbacterial-lethality characteristics within the test-ampoule with thebacterial-lethality characteristics of food spoilage bacteria in thefood(s) being processed. As taught herein, the bacteria for thetest-means are selected to respond in a manner correlated with bacteriaassociated with the foods being processed. A predominate microorganism,considered important to be eliminated in most batch-processedcontainerized-food production for non-refrigerated marketing, isClostridium botulinum (BOT); which is a micro-organism that producesspores, and which is capable of producing toxic results in certain suchfoods. These testing predeterminations and preparations are described,in greater detail in relation to later occurring FIGURES.

FIGS. 1 and 2 present graphical data for describing temperature-rangeconcepts relating to the test-means, and to utilization of such testmeans, as part of the invention. More specifically, such data is used tofacilitate correlating adequate thermal-processing of a containerizedfood production system, with measurable and timely results in utilizingthe test-methods and test-ampoule-means of the invention.

Thermal-processing combines selecting an elevated-temperature and atimed-exposure at such temperature, in order to achievebacterial-lethality; that is, to achieve “biocidal destruction” ofspore-producing food-spoilage bacteria associated with the food(s) beingprocessed. “Destruction” of bacteria, as used herein, means not onlykilling those bacteria; but, also, destroying any capability:

(i) for reproducing by division of individual bacterial cells, or

(ii) for producing-spores by those bacteria.

The graphical data of FIG. 1 also facilitates selecting culturingtemperature(s) to be utilized in a biological-indication-test forbacterial-lethality effectiveness which verifies a chemical-changeindication, available more directly following completion of suchexposure of a test-ampoule. The data of FIG. 1 also contributes toidentifying proper storage for test-ampoules prior to actual usage; thatis, storage at a temperature, where no bacterial spore germination andno bacteria-cell growth can take place, with the bacteria selected forthe test constituents.

It is emphasized that culturing temperature for test-ampouleconstituents:

(a) can differ greatly from thermal-processing temperatures ofproduction-operations for destroying bacteria; however, spore culturingtemperatures,

(b) can readily-overlap with non-refrigerated temperatures encounteredwithin containerized-production during non-refrigerated marketing; and,also (c) can differ greatly from the temperatures at which assembledtest-ampoule constituents of the invention should be held, prior todesignated usage; such latter temperature range is selected so as tomaintain and sustain test-capabilities of such ampoule constituents fortesting of subsequent production-processing operations.

As part of the invention, bacteria are selected to:

(i) correlate thermal-processing response of:

-   -   (a) bacteria contained in the test constituents, with    -   (b) bacteria contained in food(s) being processed.

Further, preparatory testing concepts of the invention also involveanalyzing for properties, such as the pH level of the food, or foods,for specified batch-food processed containerized-production operations.

In describing analytical preparatory steps of the invention, and theirfunction(s), reference is also made to the graphical data of FIG. 2.Constituents for a test-ampoule of the invention are also selected so asto provide for favorable measurable microbial-action; for example: adesired bacterial-lethality response, internally of the ampoule, whichis correlated with the thermal-processing results, due to destruction ofspore-producing bacteria contained in, or associated with the food(s)being thermally-processed, as part of the batch-food containerizedproduction operations.

Predeterminations of inherent pH values, for the differing types offoods being processed are taken into account for thermal-processing; soas to provide more efficient thermal-processing; and, so as tofacilitate testing the effectiveness of the thermal-processing.Clostridium botulinum (BOT) bacteria have been chosen as the mostversatile bacteria across a range of packaged products being developedfor non-refrigerated marketing. Such that, pH values can also berelevant in considering differing non-refrigerated shipping andmarketing conditions. BOT bacteria are particularly useful where safetyof the consumer is being considered; that is, a major considerationherein, and a main concern is human safety.

For example; Clostridium botulinum will not grow in high-acid foods;such that: thermal-processing and testing of high-acid foods takes intoconsideration other health or taste factors. A pH level 4.6, fortomatoes, separates high acid foods from low acid foods; and, low acidfoods, such as asparagus, meat and fish, having higher pH numbers,require higher levels of thermal-processing to provide for desiredmicrobial-biocidal-action for non-refrigerated marketing.

Also, as taught herein, constituents for test-ampoules are selected tohave characteristics similar to characteristics of the batch-processedfood(s) of the containerized production-operations. However, also to berecognized, is that many low-acid containerized foods would qualify as aculturing medium for live bacteria, if any, under the non-refrigeratedtemperatures normally-encountered during warehousing or shipping formarketing. Recognition of such culturing capabilities is taken intoaccount in the planning for and in test evaluations ofbacterial-lethality, following production operation.

Thermal-processing combines both elevated-temperature, and sufficienttime at that temperature, for destruction of live spore-producingbacteria associated with a food, or a combination of foods as confrontedwhen soups are being processed. An overall objective of the invention isto provide for, and to test for, adequate thermal-processing conditionsof food(s) being processed; while also providing for microbial-biocidalaction on container interior surfaces; so as to be similar to the effecton the contents of test-ampoules, as selectively positioned inmonitoring-containers. The food-spoilage bacteria for the test-ampoulesare selected and confined within test-ampoules of the invention, so asto react similarly to bacteria encountered throughout batch-foodthermal-processing of various specified containerizedproduction-operations.

In addition, the configuration, constructional-materials, and the sizeof a test-ampoule of the invention are selected to take into account thesize and texture of the food(s) to be processed, as well as the type ofpackaging. Combining those measures facilitates accurately evaluatingthe effectiveness of thermal-processing, in destroying food-spoilagebacteria, for reasons of human safety.

In addition, however, those objectives also help to providepromptly-available test-evaluations of results of thethermal-processing; which can help to prevent over-processing in ongoingoperations. That is, accurate and timely evaluation of effectivethermal-processing operations can help to avoid the undesirable flavor,texture, or appearance of food(s), which can be expected fromover-processing; and, can be helpful in planning for selected productionoperations on similar foods.

Relatively high acid-level foods, which exhibit relatively low pHnumbers extending up to about four point six (4.6), enable diminishingthermal-processing for non-refrigerated packaging of those foods, so asto enable concentrating on non-toxic characteristics forcontainerization in selected production operations. Relatively high saltor sugar content can also inhibit microbial-growth so as to diminishthermal-processing for toxicity requirements. Prompt availability andease of obtaining lethality test-results, as taught herein, can behelpful in more promptly determining whether the thermal-processing fordestruction of bacteria, should properly be increased or decreased inon-going production-operation; or, in planning, similarly-processedproduction-operation.

For spore-destruction purposes lower-acidity level foods requirehigher-levels of thermal processing, which can be a factor in selectingthe type of batch-food production thermal-processing. An increase inthermal-processing temperature level, and/or the time-duration at thatthermal-processing temperature, can be combined. The objective is properthermal-processing so as to enable accurate and prompt evaluation ofintended destruction of food-spoilage bacteria in batch-processed foods,and on container-interiors selected for thermally-processedcontainerized-production operations.

Analyses of such preparatory determinations, as pH level(s) for thefood(s) enable more accurate correlation of test-ampoule results withactual results on the food(s) being processed and containerized. And, bymaking test results available more promptly, enables fine-tuning ofthermal-processing to be carried out more promptly, or accomplished in atimely manner for similarly-planned production operations. For example:numerical pH values are taken into account:

(i) in assembly of test-ampoules,

(ii) in applying testing methods of the invention, and,

(iii) in helping to promptly and accurately verify destruction, or lackthereof, of spore-producing food-spoilage bacteria of specific food(s)during selected batch-processing containerized-production operations fornon-refrigerated marketing.

In carrying out the invention, selected spore-producing food-spoilagebacteria are confined within an individual-sealed test-ampoule so as tobe exposed to thermal-processing of the food production-operation. Testconstituents are selected to facilitate a visual-type of evaluation ofthe batch-food production operations; which can be available promptlyfor properly limiting thermal-processing for both safety; and, forprotecting food quality in similarly planned processing operations. Afurther available test-evaluation, for verifying the microbial-biocidalstatus utilizes a “biological-indication”, in which spore-culturingsolution within the test-ampoules, enables culturing conditions to bepromptly carried-out relying upon the color-change indications; however,both such evaluations are carried out while all contents remain confinedwithin the test-ampoule; avoiding any chance of contamination whichcould effect test results.

Further, a “positioning-arrangement” concept of the invention whichsubstantially increases production capabilities and diminishes losses,involves limiting the number of evaluations of containerizedtest-ampoules which should be, or need be made; while, at the same timeenabling extension of results of a limited number ofpositionally-arranged monitoring-container test-ampoule evaluations toenable accurately evaluating a substantially-greater number ofcontainers, associated in the containerized production operations, bythe positional arrangement concept of containers with test means.

A sealed test-ampoule, containing test constituents is immersed infood-contents of such a selected limited number of individualmonitoring-containers. Such monitoring-containers which individuallyconfine a test-ampoule of the invention, are positionally-located inparticular, during retort-operations, in a manner so as to preciselyidentify a substantially greater number of associated-containers. Suchassociated-containers are positioned intermediate such monitoringcontainers which include test-means, so as to experience substantiallythe same thermal-processing as such positionally-arranged monitoringcontainers.

After cooling down from thermal-processing conditions, individualtest-ampoules from individual positionally-selectedmonitoring-containers, are accountably removed, from apositionally-identified monitoring-container for testing. As taughtherein, selective-positioning of such individual monitoring-containersin preparation for and during thermal-processing, is used to identifysuch substantially-greater number of associated-containers whichexperience substantially the same thermal-processing, because ofpositioning, for example in-line, intermediate of monitoring containersduring production operations. Those concepts increase the range, and theextent of measured results, notwithstanding that a substantially lowernumber of test-ampoules from such individual monitoring-containers needbe evaluated; which is also described in more detail in relation tolater FIGURES.

FIGS. 3(a) and 3(b) each present an elevational view of rigid-typetest-ampoule means, for use in substantially-rigidmonitoring-containers. Such rigid-glass exterior test-ampoules, permituse in thermal-processing liquids. Each such rigid-type test ampoulecontains spore culturing nutrients, a pH indicator, and the selectedbacteria.

If bacteria survive, provisions are made for prompt visual-detection ofcolor-change of such liquid constituents. Also, provision is made for asubsequent biological-indication of microbial-status, by establishingculturing conditions for the test-ampoule; while all its contents remainsealed within the exterior container. Rigid-type test-ampoules areavailable from SGM Biotech, Inc. of 10 Evergreen Drive, Suite #E,Bozeman, Mont.; owner of the present application. A rigid-typetest-ampoule as shown in FIG. 3(a) is a MAGNAAMP® indicator; and 3(b)presents a STERILAMP® indicator, available from the same source. Bothcontain test ingredients providing for a color-change initial indicationof processing effectiveness; and, also, provide for subsequentbiological-indication of microbial status, following exposure of thetest-ampoule to culturing conditions. Use of such rigid-typetest-ampoules of the types shown in FIGS. 3(a) and 3(b), is preferablylimited to suitably-rigid type processed-food containers.

Test-ampoules, which are free of any concerns fracturing, as describedlater herein, are provided for softer-packaged batch-processed foodproduction operations. The description of FIGS. 4(a) through 4(f) relateto selecting materials for, and fabricating pliable non-rigidtest-ampoules; which are particularly for use with foods containerizedin other than the suitably-rigid type containers, as described herein.

In FIG. 4(a), a thin-flexible, clear polymeric sheet material, whichprovides the necessary strength, and visual clarity characteristics, isinitially fabricated so as to present an elongated hollow tubularconfiguration. One end of that elongated configuration is sealed by useof a heat-sealing apparatus, shown in later FIGURES, which establishes athin sealing line, across the tubular width, contiguous to onelongitudinal end of the elongated hollow-tubular configuration, as shownin FIG. 4(a). Such thin sealing line should be protected by heat-moldingat portions similarly-extending widthwise; and preferably locatedcontiguous on each longitudinally-located side of such sealing line.Such heat-molded protection of a sealing line can also be, andpreferably, is used in fabricating individual test-ampoules, as shown inlater FIGURES, positioned along the length of the elongated tubularconfiguration.

As shown in FIG. 4(b), the interior of the elongated flexible-polymerictubular configuration is selectively filled with test-ampoule contents.The latter include;

(i) liquid-state constituents as mentioned above and later described inmore detail,

(ii) selected spore-producing food-spoilage bacteria (such as BOT), and

(iii) means provided for detecting a chemical change in of such liquidcontents, if any bacteria survive the thermal-processing; the functionalinterrelationship of each of the above is described, in more detail,later herein.

Sufficient contents are provided in the elongated tubular configurationof FIG. 4(b), so as to enable fabricating a selected number of polymerictest-ampoules. The steps for fabricating individual polymeric testampoules are depicted in subsequent FIGURES. FIG. 4(c) shows a type ofheat-impulse apparatus which can be utilized for sealing ends; as wellas a selected number of individual polymeric test-ampoules; such as“Impulse Sealer”; is available from:

-   -   Uline Shipping Supply Specialist    -   2105 S. Lakeside Dr.    -   Waukegan, Ill. 60085

As seen in FIG. 4(d) closing of such a heat-sealer apparatus establishesa sealing line for test contents of each polymeric test-ampoule. FIG.4(a) presents a perspective view of a distal-end formed sealing line;which is preferably protected by a contiguous heat-molded portion, oneach longitudinal-side of the individual heat-sealing line. FIG. 4(c)shows use of the heat-sealing apparatus for fabricating an individualtest-ampoule of the type to be provided contiguous to such sealedlongitudinal end of the tubular configuration.

FIG. 4(d) shows operation of the heat sealer apparatus. Each individualtest-ampoule, as shown in FIG. 4(e) is substantially filled with thenamed liquid-state constituents and other contents. A minor amount ofair, which had been dissolved in the solution, can also be present, asshown, notwithstanding that a previous, at least partial, evacuation ofliquid contents had been carried-out. However, such limited presence ofair can be useful dependent on the type bacteria used in the test-means.

Air (oxygen) is present during preparation of foods at least in-partduring the above-named containerized production-operations. Withdissolved air present for the subsequent evaluations utilizing suchpolymeric test-ampoules, as shown in FIGS. 4(e) and (f); suchtest-ampoules and the foods being processed are thus correlated in thatrespect.

The elongated tubular configuration of FIG. 4(b) is sealed at selectedintervals, along its length, to form individual test-ampoules as shownin FIG. 4(f); each sealed width-wise between individual ampoules; and,at longitudinal-ends of such elongated configuration which formsmultiple test-ampoules. Such thin sealing lines, for anindividual-ampoule, are preferably additionally protected by an adjacentheat-molded portion extending width-wise on each longitudinal side of atest-ampoule sealing line; such heat molded portions facilitate laterproper separation of individual ampoules along the length of the tubularconfiguration. Each test-ampoule confines, internally, the desiredvolume of culturing medium, an indicator/detector responsive tochemical-change, if live bacteria or spores survive the thermalprocessing; and, selected spore-producing food-spoilage bacteria.

Internal-capacity for such test constituents is selected in a range ofabout one cubic centimeter (cm³) to about two cubic centimeters (cm³)for use with the popular, individual consumer-sized, containers.Larger-sized test-ampoules can be fabricated when useful for largercontainers of the type used in supplying commercial eateries, and thelike.

Representative stable thermoplastic polymers, available as thin,flexible-film for fabricating test-ampoules include:

Polypropylene (PP)

Polymethylpentene (PMP)

Polyvinyl Chloride (PVC)

Polysulphone (PSP)

Polyamide (such as Nylon 6-6);

and, combinations thereof.

Such pliable test-ampoules could also be fabricated fromnewly-developing polymers, or other combinations of polymers, which havesimilar chemical-resistances and fabricating characteristics asabove-described. Any such added or newly developing polymer can beselected, and qualified, based on the above-disclosed criteria and thephysical and mechanical data provided herein, relating to: test-ampoulescapacity, heat-stability for desired thermal-processing, and otherdesignated characteristics, which enable evaluating the status ofthermally-processed containerized food production operations fornon-refrigerated marketing.

A liquid carbohydrate-based culturing-medium is selected, for theearlier described rigid and pliable polymeric-tubular test-ampoules.That medium will support growth of live spore-producing thermophilefood-spoilage bacteria within a test-ampoule; if any survive thethermal-processing of the selected production-operations. Constituentsfor a test-ampoule culturing medium, comprise selections ofcarbohydrates, sugar, starch, etc., which can be formulated tocorrespond to “culturing” characteristics of the food(s) being processedand evaluated. Related objectives are to;

(i) provide for correlated selections of bacteria;

(ii) with substantially the same culturing properties for both:

-   -   (a) the test-ampoule constituents, and    -   (b) the containerized food; so as to:

(iii) correlate accuracy and promptness of test evaluations forbacterial-lethality.

A preferred culturing medium for test-ampoules of the inventioncontains: Constituent: Gram(s)/Liter (i) Glucose 5.0 (ii) Tryptone 8.5(iii) Soytone 1.5 (iv) Soluble Starch 1.0 (v) Yeast Extract  0.5; (vi)Casamino Acids 4.0and, in addition

(vii) a pH indicator/detector, as selected from the group consisting of:

-   -   (a) Bromcresol Purple,    -   (b) Bromthymol Blue, or    -   (c) Phenol Red.

Bromcresol Purple is frequently selected because of distinctcoloration-effects; and, for freedom from side effects on remainingtest-ampoule constituents; or, on the culturing reaction relied on forthe biological-indication of microbial-biocidal status. BromcresolPurple is selected at a level of about 0.0024 Gram/Liter, of the aboveculturing-medium for a test ampoule of the invention. Bromcresol Purpleestablishes the color purple for the test-ampoule constituents. Achemical-change in acidification, resulting in microbial growth changesin color to yellow in response to the presence of live spore-producingbacteria, if any; such change in acidification is also utilized for abiological-indication of microbial status; that is, bacterial-growthresponding to culturing conditions causes acidification.

A representative culturing temperature, for such biological indications,is above about 55° C. to 60° C., (about 131° F. to 140° F.). Suchtemperature is maintained in order to establish culturing conditions forsuch test ampoule, after removal from a monitoring-container. Dualtest-results can then be obtained; and, as briefly described earlier;those results on selected bacteria within a test-ampoule, as submersedin a monitoring-container, can be correlated with thermal-processingresults on in-line additional containers identified by the positionallyarranged containers. For example, if any live bacteria survive, both ofthe above microbial-action determinations correlate results within thetest-ampoules of monitoring containers positionally-arranged to identifynumerous additional containers by the location of themonitoring-containers from which the test-ampoules are taken.

Thus a limited number of individual monitoring-containers, each with anindividual test-ampoule, are utilized by proper-placement duringproduction processing to identify a significantly greater number of“associated-containers” which experience substantially the samethermal-processing. Pre-placements of such monitoring-containers in-linewhen utilizing retort-means for thermal processing facilitates theaccuracy of identifying the substantial greater number of “associated”containers. Aseptic-flow processing depends on placement ofmonitoring-containers in the flow-line.

For example, numerically-extended results can be achieved, by placementsat both the leading and the trailing ends of a selected in-line flowpath. Such placements identify a substantially-greater number ofintermediate-located associated-containers, which as exposed tosubstantially the same thermal-processing, are evaluated by individualtest-ampoule, immersed in such strategically-located individualmonitoring-containers, located at the leading and at the trailing endsof each such in-line travel path.

It should be noted that an in-line monitoring-container at thetrailing-end of a designated flow path, can be utilized to provide anevaluation for the leading end of the next succeeding in-linetravel-path; that is, such a trailing-end test-ampoule can be used asthe leading-edge indicator, by selectively establishing a position for amonitoring-container at the trailing end of the next in-line travelpath.

Individual test-ampoules are removed from monitoring-containersfollowing cool-down subsequent to the thermal-processing of the selectedproduction system; so as to enable obtaining a visual color-change; duefor example to the Bromcresol purple. If bacteria have survived, such achange in color to yellow, due to inadequate exposure during thermalprocessing operations, can be determined as visually-aided in a matterof hours; and, a biological-indication of microbial-status can beobtained by utilizing culturing conditions. That is, survivingspore-producing bacteria within such a test-ampoule produce acid if thethermal-processing has not been adequate; thus, providing for both colorchange indication and a biological-indication responsive toculturing-conditions.

Visual detection of color change, or absence thereof, visually-unaided,can be detected within about forty-eight (48) hours of suchproduction-operations. A biological-indication verification of microbialstatus can be aided by detection means responsive to change inhydrogen-ion concentration. Test-ampoules of the invention combineselected spore-producing food-spoilage bacteria, and detector/indicatorsresponsive to microbial action, if any bacteria-cell growth, or anybacterial spore germination occurs following the thermal-processing.Multiple determinations of microbial-biocidal experience are available.For example, chemical-reaction color-change in the test-ampoule solutionindicates survival of bacteria. Destruction of food-spoilage bacteriacan be selectively determined by visually observing such a color-changein accordance with the invention; and, further, by biological-indicationof response by surviving bacteria; detecting increased hydrogen-ioncontent can be used to expedite that biological-indication.

If the determined status indicates that bacteria in at least onetest-ampoule, of a pair identifying an in-line travel path, havesurvived the thermal-processing; in addition to

(i) finding and eliminating the cause of such inadequate-thermalprocessing,

(ii) identifying and preventing distribution of associated-containers,which were located so as to also have been inadequatelythermally-processed, are also required.

Establishing that such associated-containers experience the samethermal-processing in an aseptic-flow system involves timed flow-lineintroduction of a monitoring-container into the flow; so as to positiona test-ampoule at each leading and trailing end of a designated-lengthin-line flow-path, so as to determine thermal-processing experienceduring such aseptic-flow. Subsequent evaluation of a test-ampoule from amonitoring-container at both the leading and trailing ends of such timedin-line flow-path, provides for proper bacterial-lethality evaluation ofintermediately-located-containers.

Production-operations using agitation-type retort-equipment, as well asthe thermal-processing of an aseptic-flow system, each can involvestrategically-positioning a designated individual monitoring-container,at both the leading and the trailing ends of a designated in-line travelpath for associated-containers. Such travel paths are selected,designated, and used to establish that a substantially-greater number ofintermediately-located-containers, experience substantially the samethermal processing as the strategically-positionedmonitoring-containers. Individual test-ampoules for both the leading-endand trailing end monitoring container are then evaluated; and, thatsequencing can then be continued, as earlier described.

Agitation-type retort-equipment, as shown schematically in FIG. 5, islargely used for containers having rigid characteristics which arecapable of assisting in impelling movement along in-line travel-paths,within such equipment. For example, a rolling-action is available withcylindrical-configuration rigid flat-rolled sheet metal cans, whichincreases the capacity of the retort equipment. Assistance in impellingmovement, is used in the agitation-type retort-equipment layout of FIG.5; and, causes agitated movement of contents within containers. Thelatter helps to make the intended thermal-processing more uniform oncontainer contents; and, on the contents of individual test-ampoules. Arigid-type test-ampoule of a type described in relation to FIGS. 3(a) or(b), can be used in an individual monitoring-container at theleading-end with another individual monitoring container at thetrailing-end of such an in-line travel-path.

In agitation-type retort-equipment as shown, passageways are preferablyheated with saturated steam; although pressurized super-heated watercould be provided for, and could be used. Saturated steam temperaturesare suitably selected for the containerized food, starting at 212° F.(100° C.). Pressurized super-heated water temperatures start above 212°F. (100° C.) and can extend in a range of to about 225° F. (107.2° C.)to 250° F. (121.1° C.). Also, individual containers each with aone-piece substantially-rigid polymeric can body and a singlerigid-sheet metal end closure, can be supported for vertical-travelthrough vertically-oriented heated-passageway in-line travel paths.

The length of a pre-determined in-line travel-path is selected, based ondisclosed methods, in which strategically-placed monitoring-containers,each containing an individual test-ampoule, can be relied on todetermine the status of associated-containers travelingsubstantially-identical travel paths. As disclosed above, amonitoring-container is placed at both the leading and the trailing endsof such a designated in-line travel path.

In FIG. 5, individual containers can enter the retort-equipment alongthe path indicated by directional arrow 50; and, travel upwardly alongthe direction of arrow 51. The containers continue to travel into acurved path indicated by directional arrow 52; then, downwardly in thedirection of arrow 53 toward the exit direction indicated by arrow 54.Cylindrical configuration sheet-metal sealed-cans, which can be readilyrotated about their central axis during such travel, are preferred foruse in such changing-direction travel-paths.

In order to have analyses of monitoring-containers with immersedtest-ampoules correlate with thermal-processing of a plurality ofin-line associated-containers, strategic-placement ofmonitoring-containers is established by analyzing such criteria as:

(i) rate of thermal-processing to be provided by retort-equipment;

(ii) pH level of the food(s) being processed; and

(iii) the type of food-spoilage bacteria, associated with the food beingprocessed.

Rate of thermal-processing involves in-line travel time, which can bereliably estimated, during preparatory analyses steps of available heatand line-speed, so as to determine the number of containers which can bethermally-processed during a selected timed-interval in anumerically-designated travel-path. Overall capacity of retort-equipmentfor cylindrical sheet-metal cans, can be designed with significantvariety. As an example, cylindrical containers in a selectedtravel-path(s) could extend in a range from about one hundred to fivetimes that number, by properly coordinated batch-food productionoperations with retort thermal-processing operations.

In operating retort-equipment schematically-shown in FIG. 5, at location55 a monitoring-container, with immersed test-ampoules could reachthermal-processing temperature at that entrance to the travel-path(s)selected for the retort-equipment. A time-at-temperature could beselected for an in-line travel-path to complete thermal-processing;which could extend over an initial travel-path length of about onehundred cans; extending to a centrally-located position, as shown at 56.A container removed at 56 would comprise the leading travel-pathmonitoring-container; and, one hundred in-line cans later, thetravel-path trailing-end monitoring-container is available. Evaluationsof those two monitoring-containers would then determine the status ofthe significantly-greater number of associated-containers in theselected travel-path.

Where increased thermal-processing is required, themonitoring-containers with test-ampoules, and the associated-containerscould travel an extended-length path of such illustratedretort-equipment apparatus; for example, extending to exiting location57. Dependent on the above-described retort-equipment operatingcriteria, locations for monitoring-containers with an immersedtest-ampoules, could then be located at the entrance to, and exit from,such an extended travel-path, which would extend thermal-processingtime; and, the microbial-status of an increased number ofintermediately-located associated-containers would be available.

FIG. 5(b) is a perspective view of a flat-sided composite-material usedlargely for aseptically-processed packaged products such soups; as wellas larger quart-size soy-milk packaged for non-refrigerated marketing;until opened. Externally-visible cardboard surfaces for those types ofcomposite-material containers, positional thin-metallic foil internallyof the composite for protection of the product; and, both the interiorand exterior surfaces of such foil are laminated with one, or more,polymeric-film layers. Instructions for use, and for describing thecontents of the package, are on the exterior surfaces the cardboard;which is also protected by at least a single polymeric layer.

Cup-shaped configurations for substantially-rigid containers can befabricated with a one-piece rigid-polymer can body, with arigid-flat-rolled sheet metal “easy-open” end closure; as represented byFIG. 5(c); which could utilize in-line travel-path configurationproviding for vertically-movable support structure adapted to thatconfiguration, in retort-equipment of the type described in relation toFIG. 5. other-configuration containers which combine a rigid-typepolymeric cup-shape, with an “easy-open” rigid flat-rolled sheet metalend closure; can also be accommodated. For content consumption purposes,the open-end is covered, after removal of the easy-open end, with aplastic cover which enables microwave heating. In addition toretort-cooker thermal processing as described in relation to FIG. 5,another production-operation option for such containers is use ofaseptic-flow capable of handling selected-characteristics and cut-sizessuitable for containerization in aseptic-containers.

FIGS. 5(d) and 5(e) are plan views of packaging utilizing arelatively-thinner less-rigid polymeric-pan for receiving food contentsduring food-preparation operations. The upper surface of such a pan issealed with polymeric sheeting. Such less-rigid pans can present asingle compartment as shown in FIG. 5 (d); or, multiple compartments asshown in FIG. 5 (e). Such packaging concepts of FIGS. 5(d) and 5(e)broadly rely on described testing principles of the invention forevaluating thermal-processing. However, “stationary-type”retort-equipment shown in FIGS. 6 (a) and 6 (b), as taught herein, canbe utilized. Such chamber-type retort-equipment has been devised, inparticular, for handling such low-cost above-described semi-rigidpolymeric shallow-pans sealed with a polymeric sheet cover. Suchstationary retort-equipment, can also be used for non-rigid pouch-typelaminated polymer containers which are later packaged, in a cardboardshell, which describes contents, presents instructions fornon-refrigerated marketing, and instructions for subsequent preparationand/or usage of food contents.

No inter-active movement-impelling force between containers is relied-onin such stationary-type of retort-equipment. Such semi-rigid sealedshallow-pans, and/or such special laminated-polymer pouches, aresupported on individual vertically-spaced shelves, as shown in FIG.6(a). Such vertically-spaced shelves can be mounted on a single-rack,which substantially fills the entire stationary retort-chamber. The sizeof the rack, the chamber, and entrance and/or exit doors, areestablished to enable movement of a full-rack into and out of astationary-type retort-chamber for thermal-processing of the selectedproduction-operations.

A heated-jacket is preferred, for such stationary-type retort-equipment,which facilitates completing thermal-processing in shorter time-cycles.The stacked shelves and rack are preferably fabricated to facilitatechamber entrance and exit; and, to match the internal configuration ofthe retort-cooker chamber. That provides for single-step full loadingand unloading of the chamber; and, minimizes heat-loss between cycles.

Use of saturated-steam in the thermal-processing concepts of FIG. 6(a),with heated-jacket walls help to desired readiness, and, to help providefor uniformity of thermal-processing at the selected temperature.Saturated steam is supplied at 212° F. (100° C.) to the chamber by one,or more, elongated rows of steam inlets along the full length of theupper portion of the chamber. Steam inlet provisions are coordinated soas to facilitate removal of air, and any condensate of the steam, undercontrol of thermo-static valves which are located at one or morelocations along the lower portion of the stationary-positioningretort-chamber. Directional-control of the saturated-steam can beimplemented by baffles where helpful. Additional steps, such aspositioning larger containers near upper portions of the chamber, can betaken to help to provide desired uniformity throughout the chamber incompleting thermal-processing of the selected production-processing. Acontributing factor to uniformity involves introducing steam, at upperlocations, so as to help to drive the heavier air toward the lowerportion of the chamber; for exit from the chamber through thermostaticvalve(s) at lower locations. That augments heating of the load andexpedites accomplishment of the “time-at-temperature” portion ofthermal-processing.

Those measures are utilized to facilitate establishing and maintaining aselected uniform thermal-processing temperature throughout the chamberduring thermal-processing; and, to facilitate re-establishing suchconditions for each retort thermal-processing batch cycle. Timing ofthermal-processing is selected depending on the food(s) being processedas discussed earlier, in practice, saturated steam is provided at atemperature of at least 212° F. (100° C.) for a designated timeduration.

The chamber of FIG. 6(b) provides for use of water heated withsuperheated steam; and provides for holding the packaging in place atvarious levels of the rack which occupies substantially the full chamberthermal-processing for the selected production operation is carried outwith steam at about 225° F. (107.2° C.) to 250° F. (121.1° C.).

In FIGS. 6(a) and 6(b), monitoring-containers with immersed test-ampoulemeans are positioned at predetermined chamber locations on the rack.Those locations are predetermined based on achieving the desireduniformity of thermal-processing of associated-containers. Thatuniformity is implemented by selecting easier-to-heat packaging fordifficult-to-heat locations. Such locations are generally furthestremoved from the introduction of the heat-source, which can differ forthe chambers of FIGS. 6(a) and 6(b).

Measures have been devised for introducing pressurized steam forsuper-heating water, by withdrawing vapors at upper portions of the FIG.6(b) chamber for augmenting heating from lower portions of the chamberfor achieving substantially-uniform thermal-processing for allshelf-mounted containers while in the chamber shown in FIG. 6(b).

Test-ampoule teachings of the invention are applicable tothermally-processing foods which contain a designated amount of freemoisture. That is, present testing methods and use of the test-ampoules,as disclosed herein, are not required and are not utilized fordry-packaged ingredients; such as: dried sauces or dried-soupingredients. Those types of contents are generally prepared, forconsumption, by adding water or milk, followed by a boiling-type cookingin preparation for eating.

Food-spoilage bacteria do not multiply or produce spores in the absenceof an abundance of free-moisture. Test-ampoules and testing methods, asdescribed herein are not utilized in the absence of free-moisture whichenables spore growth; and, also, facilitates destruction of bacteria, asdescribed herein.

Soft-packaging pouches free of any rigid portion, can also be readilythermally-processed in stationary retort-equipment, as shown in FIG.6(a) using saturated-steam. Such non-rigid soft-packaging, afterverification of thermal-processing by use of selectively-positionedmonitoring-container(s), is then further packaged, individually, or ingroups, in semi-rigid light-weight cardboard casings which includeidentifying labeling and instructions for usage. Such casings are alsohelpful in making store shelf displays and in providing protection forthe soft-packaging.

Aseptic-flow thermal processing relies on a high temperature (293° F. to320° F.) (145° C. to 160° C.) short flow-line time; with selectedmaterials relied on for sterilizing the interior of an asepticcontainer. An aseptic-system sequence of steps is described further inthe text of the box-diagram flow chart of FIG. 7. Cream-style soups suchas broccoli or chicken are readily flow-processed prior to being fedinto aseptic containers as fabricated, for example, within a metallicfoil liner with polymer coating(s) on inside and outside surfaces of aboxed contents, as described in relation to FIG. 5(b). Contents whichinclude sized pieces of meat or vegetable can also be asepticflow-processed for substantially-rigid containers as shown in FIG. 5(c).Test-ampoules are periodically immersed along an in-line aseptic-flowpath starting with initiation of aseptic-flow thermal-processing; and,periodically thereafter, depending on the designated flow-rate, inaseptic monitoring-containers before sealing of these containers.

Locations for monitoring-container(s), with immersed test-ampoules, areselectively identified and designated based on the in-line aseptic-flowproduction rate. In that manner, a selected number ofassociated-containers is established for an in-line flow-path, bypositioning a test-ampoule for disposition in a designatedmonitoring-container; with such a designated monitoring-container beinglocated at the leading and/or trailing ends of each such in-lineflow-path, for identifying a plurality of intermediately-locatedassociated-containers.

Control of aseptic-system flow enables tagging the locations formonitoring-containers, each of which includes a test-ampoule immersed infood-contents. Subsequent to aseptic flow processing and asepticcontainerization, test-ampoules of such designated monitoring-containerscan be evaluated for microbial-action which can be measured in severalways, as described earlier; relying on surviving bacteria, if any,increasing the acidity of the liquid test contents so as to produce avisibly-detectable color-change; and, which can also be determined byelectrometrically or spectroscopically measuring hydrogen-ion activity.Constituents of an individual test-ampoule, as removed from suchdesignated-location monitoring-containers, which are positioned toestablish status of associated-containers, as previously described.

The descriptions of steps for the systems of FIGS. 7 and 8, facilitateaccurate analyses of the status of associated containers, based onanalyses of immersed test-ampoules in strategically-located ortimed-interval flow locations of monitoring-containers in FIG. 2. Asdescribed above, a monitoring-container is located at the leading andtrailing ends of designated, flow paths so as to verify thethermal-processing status of a substantially greater number ofintermediate associated-containers in the flow. That concept minimizesthe number of containers which need be unsealed for retrieval of atest-ampoule, for verifying the status of a substantially greater numberof containers in the aseptic production-operations.

Containerized food-production operations using retort-equipment can takeinto account thermal-exposure, if any, carried out during a foodpreparation stage, while fulfilling or augmenting a major portion of thethermal-processing utilizing subsequent retort operations, as describedfurther in the box-diagram flow-chart sequence of FIG. 8. Thoseoperations provide for evaluation of results in associated-containers byrelying on strategically-located monitoring-containers each including atest-ampoule for evaluating effectiveness of the microbial-biocidalaction, which is applicable to a plurality of associated-containers, asdisclosed above.

Embodiments of the invention have been described with a degree ofparticularity. However, it should be recognized that othernon-refrigerated packaging, minor changes in test-method steps,test-ampoule-structures, configurations, combinations of polymers,test-ampoule constituents, or selection of the bacteria, for makingadditional evaluations are made accessible, in the light of the aboveteachings. Therefore, reference should be made to the accompanyingclaims and to the above terminology for evaluating the valid scope ofthe invention based on the claimed combination of materials, procedures,and methods, as disclosed and described above.

1. Process for determining effectiveness of timed elevated-temperature thermal-processing of in-line batch-processed containerized food production-operations including in-line aseptic flow-processing for aseptic-containerization production-operations, for evaluating whether safe for non-refrigerated marketing, comprising (A) providing sealed test-ampoules for evaluating bacterial-lethality of batch-processed food, by: (i) selecting spore-producing-bacteria, for such test ampoules of a type associated with spoilage of such food being batch-processed, (ii) providing, (a) for fabricating such test-ampoules of selected configuration and internal capacities, (b) for confining contents including such spore-producing bacteria plus liquid-state test constituents, and (c) for remaining sealed during thermal-processing and following bacterial-lethality evaluation; (B) confining such spore-producing food-spoilage bacteria and liquid-state test constituents within an individual test-ampoule of said test-ampoules; (C) placing individual test-ampoules for monitoring thermal-processing, so as to enable (D) correlating: (i) biocidal results on spore-producing bacteria as sealed within such individual test-ampoules for monitoring thermal-operations with (ii) biocidal results achieved on such spore-producing bacteria associated with such foods for containerized production-operations.
 2. The invention of claim 1, further including (E) selecting test-ampoule contents to include, in addition to said spore-producing bacteria, (i) means for responding to chemical-change in confined constituents within each such individual test-ampoule for monitoring thermal-processing, by (ii) providing for a visually-detectable indication as to whether any such bacteria survived such thermal-processing within such a test-ampoule.
 3. The invention of claim 2, in which (iii) pH detector/indicator means provide for exhibiting color-change in contents of such a test-ampoule by responding to surviving bacteria, if any.
 4. The invention of claim 3, further including (F) positioning such a test-ampoule in a limited-number of such containers for monitoring thermal-processing so as to identify a substantially-greater number of containers, which are free of test-ampoules; which (G) experience substantially the same thermal processing as experienced by such positioned individual containers which include a test-ampoule; so as to enable: (i) evaluating bacterial-lethality by relying on test-constituents in such limited-number of containers with test-ampoules, positioned, for (ii) determining whether such greater-number of remaining containers are safe for non-refrigerated marketing.
 5. The invention of claim 4, including (H) providing for biological-indication of microbial-status following an incubation period, subsequent to production-line operations, available by (i) establishing culturing conditions for each said individual test-ampoule designated for monitoring thermal-processing as strategically-locating during production-line thermal-processing, so as to (ii) verify microbial-biocidal status of such substantially-greater number of containers experiencing substantially the same thermal-processing as such strategically-located containers containing test ampoules.
 6. The invention of claim 5, in which (I) means for verifying microbial-biocidal status of such designated containers with test-ampoules area, selected from the group consisting of (a) spectroscopic means for measuring hydrogen-ion activity, and (b) non-evasive electrical measuring means for indicating hydrogen-ion activity.
 7. Non-rigid polymeric test-ampoule for use in evaluating bacterial-lethality effectiveness of elevated-temperature thermal-processing, on food-spoilage bacteria associated with batch-processed food production containerized in substantially non-rigid packaging, for determining whether safe for non-refrigerated marketing, comprising (A) selecting non-rigid polymeric sheet material for fabricating such test-ampoule, so as to be capable of: (i) establishing a desired capacity for selected constituents, (ii) withstanding elevated-temperature thermal-processing as part of such batch-food containerized production operations, while (iii) confining (a) selected food-spoilage spore-producing bacteria, in (b) a liquid spore-culturing medium, containing (c) pH responsive means, for (d) detecting chemical change due to microbial-action of surviving live bacteria, if any, in said test-ampoule, and, in which (e) such selected polymeric material, (f) maintains visual clarity during such thermal-processing and subsequent evaluation of bacterial-lethality effectiveness.
 8. The invention of claim 7, in which (B) said selected spore-producing food-spoilage bacteria comprise Clostridium botulinum, (C) said pH responsive means is selected to respond to microbial-action of surviving bacteria, if any, by: (i) exhibiting color-change responsive microbial-action due to inadequacy of thermal-processing during such food production operations, so as to be (ii) visually-observable after cool-down following completion of such food production operations, and, in which (D) such liquid spore-culturing medium provides for biological-indication of microbial status, following exposure of said test-ampoule to bacterial incubation conditions.
 9. The invention of claim 8, in which (E) said spore-culturing medium, confined within said test ampoule, comprises: (i) Glucose (ii) Tryptone (iii) Soytone (iv) Soluble Starch (v) Yeast Extract, and (vi) Casamino Acids; (F) such pH responsive means comprises Bromcresol Purple.
 10. The invention of claim 9, in which said non-rigid polymeric sheet material is: (i) substantially transparent to electromagnetic energy-wavelengths in a visible light spectrum, and (ii) non-reactive chemically with contents of said test-ampoule, during (a) batch-food production operations, (b) testing thereof, and (c) during storage prior to usage at less than spore-culturing condition temperature.
 11. The invention of claim 10, in which such polymeric sheet material is selected from the group consisting of: (i) Polypropylene (ii) Polymethylpentene (iii) Polyvinyl Chloride (iv) Polysulphone (v) Nylon, and (vi) combinations thereof.


12. Apparatus for evaluating containerized batch-food thermal-processing production operations, comprising (A) individual test-ampoules for monitoring microbial-biocidal results of such thermal-processing, which are (i) fabricated to withstand selected elevated-temperature thermal-processing during selected containerized batch-food production operations, (ii) each individual test ampoule of said test-ampoules, including: (a) spore-growth nutrient medium, and (b) food-spoilage bacteria, which are subject to destruction in response to intended thermal-processing during such production operations, and (B) means for detecting change in acidity of such nutrient medium within each said individual test-ampoule.
 13. The invention of claim 12, including C) pH means for exhibiting a color-change if any bacterial cell, or germinated bacteria spore survives such thermal-processing.
 14. The invention of claim 13, further including (D) means for subjecting such test-ampoules, experiencing microbial-biocidal results of such thermal-processing, to incubating conditions following such thermal-processing, for providing (E) a biological-indication of microbial-biocidal status of such test-ampoules, by (i) measuring hydrogen-ion concentration within such test-ampoules from containers, as strategically-positioned in-line, for (ii) identifying a substantially greater number of containers experiencing such thermal-processing, so as to be capable of (iii) indicating results of such elevated-temperature thermal-processing production operations in such greater number of containers, as identified by such selectively-positioned containers for monitoring thermal-processing, so as to determine whether (iv) such greater number of containers are safe for non-refrigerated marketing.
 15. Process for protecting food quality during containerized batch-processed containerized food production operations providing for non-refrigerated marketing, comprising (A) predetermining pH value of foods selected for such batch-processed containerized food production operations; (B) selecting minimal microbial-biocidal thermal-processing as estimated to be required during such food production operations, based substantially on such predetermined pH value, so as to enable minimizing thermal-processing; (C) selecting and confining food-spoilage bacteria internally of test-ampoules, for responding to such estimated thermal-processing, for (D) correlating microbial-biocidal action, on such selected bacteria as confined within such test-ampoules, with that required, during containerized-food production thermal-processing, for safe non-refrigerated marketing.
 16. The invention of claim 15, including (E) locating such test-ampoules as selected for responsively-correlating microbial-biocidal action, within (i) containers for monitoring thermal-processing, as positioned in-line during such production operations, (ii) identifying a substantially greater number of in-line containers, so as to enable (iii) at least a pair of test ampoules for monitoring thermal-processing, are positioned in-line during such production operations, so as to locationally-identify such substantially greater number of in-line containers experiencing substantially the same thermal-processing.
 17. The invention of claim 16, including (F) determining whether such correlated thermal-processing has been effective, so as to enable safe non-refrigerated distribution of such greater-number of containers, as subjected to such food production operations; by evaluating whether: (G) chemical-change in acidity level has occurred within such test ampoules for monitoring thermal-processing by selecting from the group consisting of (a) visually-observing color-change pH response to acidity level following such production-operations, (b) biological-indication of acidity-level response to continuing microbial-action, following such production operations, and (c) combination of (a) and (b). 